CAPA

– Corrective Action Preventive Action –

Introduction to Corrective Action Preventive Action (CAPA)

When illness strikes and we need medical attention, we put our trust in the medical products and
care givers to provide relief. We expect the care we receive is without fault. Fortunately, failure is
not experienced frequently in healthcare and medical devices. When failure does occur, we
demand a rigorous process of investigation be initiated to identify why it occurred. Corrective
Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies
causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose
of CAPA is to assure the problem can never be experienced again. CAPA can be applied in many
disciplines. A few of these disciplines are:
 Manufacturing
 Product Design
 Testing Verification and Validation
 Distribution, Shipping, Transport and Packaging
 Use-Applications

What is Corrective Action Preventive Action (CAPA)

Corrective Action Preventive Action (CAPA) is the result of a US FDA requirement, FDA 21
CFR 820.100. The CAPA requirement applies to manufacturers of medical devices and compels
them to include CAPA in their Quality Management System (QMS).
CAPA is split between two distinct but related functions.
1. Corrective Action (CA) is an extension of Root Cause Analysis (RCA). The first goal
of CA is to find the root cause, base event or error that preceded the problem. The
second goal is to take action directed at the root cause or error.
2. Preventive Action (PA) is similar to Lessons Learned / Read Across. PA resembles the
replication activity of Design for Six Sigma (DFSS). Another example of PA in
industry is Yokaten, a Japanese term used by Toyota, describing a sharing across the
organization. The primary goal of PA is to inform an organization and prevent the
problem from returning in other facilities lines or products.
 Why Implement Corrective Action Preventive Action (CAPA)

Identifying the root cause of failure is a key tenet of any effective QMS. When a problem occurs,
it is often just a symptom of the real issue. Symptoms can be treated but finding out why the
symptom is experienced is the true purpose for implementing CAPA. Failure to implement an
effective Corrective Action Preventive Action process is a violation of FDA regulations defining
Good Manufacturing Practice (GMP).
Once implemented, the CAPA system must exhibit ten objectives to meet the intent of the FDA
21 CFR 820.100 requirement. The 10 objectives of CAPA implementation are:
1. Verification of a CAPA system procedure(s) that addresses the requirements of the
quality system regulation. It must be defined and documented.
2. Evidence that appropriate sources of product and quality problems have been identified.
3. Tracking of Trends (which are unfavourable) are identified.
4. Data sources for Corrective and Preventive Action are of appropriate quality and
content.
5. Verify that appropriate Statistical Process Control (SPC) methods are used to detect
recurring quality problems.
6. Verify the RCA work performed is aligned to the level of Risk the problem has been
identified with.
7. Actions address the root cause and preventive opportunities.
8. CAPA process actions are effective and verified or validated prior to implementation.
9. Corrective and preventive actions for product and quality problems are implemented and
documented.
10. Nonconforming product, quality problems and corrective / preventive actions have been
properly shared and included in management review.

How to Implement Corrective Action Preventive Action (CAPA)

There are many ways to apply the two functions of CAPA. The Quality-One Corrective Action
Preventive Action approach is as follows:

Corrective Action

When a symptom is observed or communicated, a systematic set of activities are initiated. The
activities are intended to describe the problem in sufficient detail so that the team can identify a
root cause path. Once a root cause path is selected, a permanent corrective action is identified,
verified, implemented and validated. The Quality-One nine-steps for Corrective Action are
detailed below:
1. Symptom is observed or communicated. The symptom must be quantified through the
application of five questions, or 5Q, and confirmed as a true symptom, worthy of
defining further.
2. Problem Statement is created by using the 5 Why approach, driving as deep into the
problem as data will permit.
3. Affinity or Ishikawa (fishbone) diagram is used to identify possible causes of the
Problem Statement.
4. Problem Description is written based on further investigation of the What, Where, When
and How Big data collected.
5. Possible causes on the Affinity or Ishikawa (fishbone) diagram can then be reduced by
using data from the Problem Description.
6. Theories are developed on remaining possible causes.
7. Root cause is verified by turning it on or off at will.
8. Permanent Corrective Actions are determined for root cause and inspection process
(which also failed to stop the cause from escaping).
9. Implementation and Validation of the Corrective Action.
Types of Corrective Actions
There are numerous examples of corrective actions in various industrial and business
applications. These range from:

 Major incidents. In global disasters such as the Deepwater Horizon incident in 2010,
11 workers died, 17 were injured, and 60,000 barrels of oil spilled into the sea. The
identified cause was the malfunctioning of heavy blades some 20,00 feet underwater.
A CAP would have been applied to this and all such significant incidents. In this case,
the corrective actions have led to global changes in design and maintenance processes
for similar oil & gas installations.
 Deviations from company policy. In HR terms, when employees break a company
policy or procedure, they may be reprimanded after such an action. A good example is
an employee taking time off work without any notice. In some instances, the deviation
may call for a policy change.
 Calibration of tools. In the manufacturing industry, instruments are regularly re-
calibrated to ensure they measure within set tolerance bands.
  Software fixes. Software applications where the data or the program logic provides
erroneous output. Action is taken to identify and remedy the problem.
 Human error or lack of training. Incorrect input to business applications due to
human error. This may be a genuine mistake or lack of proper training. Action is
taken to provide additional training.
 Equipment/software controls—triggers and alerts on equipment or built into
software when a parameter falls outside a tolerance level. A good example is when an
alarm sets off on equipment because the temperature exceeds pre-set limits.
 Non-adherence to a process/procedure. We were not following the set process or
procedure when completing a task. How often have we assembled furniture from a
flat pack and found ourselves so frustrated because we did not carefully follow the
instructions?

Preventive Action

Often the root cause of a root cause is the system or lack of policies, practices or procedures
which supported the creation of the physical root cause. Preventive Action (PA) occurs after the
physical root cause has been identified and permanent corrective action has been validated. PA
recognizes the value of the information and actions taken during the CA function. This
information is shared within the organization. Quality-One suggests the following steps for
Preventive Action:
1. Capture the Problem Statement as an Object-Defect for searchable databases.
2. Link root causes to the Problem Statement with the Permanent Corrective Action.
3. Identify other systems, facilities and processes which could benefit from the knowledge
captured.
4. Assure Systems Documents are updated, including but not limited to:
 Failure Mode and Effects Analysis (FMEA)
 Control Plan Methodology
 Work Instructions
5. Archive information for future retrieval including supporting information.
6. Publish and close-out team experience.
Problem-Solving and Root Cause Analysis
Regarding problem-solving and the CAP, a few other techniques are used in various
circumstances or specific industries. These techniques include:

 PDCA. Plan, Do, Check, Act. An iterative management review method controls and
continuously improves processes and products.
 DMAIC. Define, Measure, Analyse, Improve, and Control. A data-driven
improvement cycle is used for improving, optimizing, and stabilizing business
processes and designs.
 8D. A problem-solving methodology is designed to find a problem's root cause based
on the ISO 9001 technique.
These techniques complement the CAPA process.